— Tabrecta is the first and only therapy approved by the FDA to specifically target metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14)
— Tabrecta is the fourth molecule discovered by
— Novartis has exclusive worldwide development and commercialization rights to Tabrecta
MET, a receptor tyrosine kinase coded by the MET gene, normally plays an important role in cell signaling, proliferation and survival.2 Many cancers are associated with abnormal signaling through the MET receptor pathway, caused by multiple mechanisms including point mutations, insertions/deletions that lead to skipping of exon 14.2 Results from the GEOMETRY mono-1 study describe METex14 as an important biomarker for physicians to consider when selecting metastatic NSCLC treatment options; and emphasize the importance of broad molecular testing for NSCLC patients.
“The GEOMETRY mono-1 study results published in
Published data from the GEOMETRY mono-1 study demonstrate that in the METex14 population (n=97), the ORR as confirmed by the Blinded Independent Radiology Committee (BIRC) was 68% (95% CI, 48-84) among treatment-naïve patients (n=28) and 41% (95% CI, 29-53) among previously treated patients (n=69).1 In patients with METex14 who responded to treatment with Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.6-not estimable) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.6-13.0) in previously treated patients (28 responders).1
Thirteen of 14 patients with METex14 had brain metastases at baseline (3 treatment-naïve and 10 previously treated patients) and were considered evaluable by the BIRC.1 In a post-hoc analysis, 7 intracranial responses were observed, including 4 complete responses.1
The most common treatment-related adverse events (incidence ≥20%) were peripheral edema (43%), nausea (34%), increased blood creatinine (18%) and vomiting (19%). The majority of AEs were grades 1 or 2.1
NSCLC accounts for approximately 85% of lung cancer diagnoses.3 METex14 occurs in 3-4% of newly-diagnosed metastatic NSCLC cases4 and is a recognized oncogenic driver.2,5 Tabrecta is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation the leads to METex14.
Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
Full prescribing information for Tabrecta can be found at: https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf.
Tabrecta (capmatinib) is a kinase inhibitor that targets MET discovered by
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the clinical benefit of Tabrecta, and milestone payments or royalties
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the
- Wolf J, et al. Capmatinib in METex14-Mutated or MET-Amplified Advanced NSCLC. N Engl J Med. 2020.
- Sadiq AA, Salgia R. MET as a possible target for non-small-cell lung cancer. J Clin Oncol 2013; 31:1089-96.
American Cancer Society. About Lung Cancer. Available at https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed September 1, 2020.
Salgia R. MET in
Lung Cancer: Biomarker Selection Based on Scientific Rationale. Mol Cancer Ther. 2017;16(4):555-565.
- Smyth EC, et al. Emerging molecular targets in oncology: clinical potential of MET/hepatocyte growth-factor inhibitors. Onco Targets Ther. 2014; 7:1001-1014.